Cleared Traditional

K901035 - FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLE

K901035 is an FDA 510(k) clearance for FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC ..., manufactured by Cuda Products Co.. The device is a Class 2 General & Plastic Surgery device with product code FST cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K901035 · Cuda Products Co. · General & Plastic Surgery device
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Apr 1990
Decision
48d
Days
Class 2
Risk

K901035 is an FDA 510(k) clearance for the FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLE. Classified as Light, Surgical, Fiberoptic (product code FST), Class II - Special Controls.

Submitted by Cuda Products Co. (Jacksonville, US). The FDA issued a Cleared decision on April 23, 1990 after a review of 48 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4580 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cuda Products Co. devices

FDA 510(k) Submission Details - K901035

510(k) Number K901035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1990
Decision Date April 23, 1990
Days to Decision 48 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 115d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FST Device Classification - Class 2, Special Controls

Product Code FST Light, Surgical, Fiberoptic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4580
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FST Light, Surgical, Fiberoptic

All 27
Devices cleared under the same product code (FST) and FDA review panel - the closest regulatory comparables to K901035.
MEDICAM 900 AUTOELECTRONIC LIGHT SOURCE
K922544 · Kirschner Medical Corp. · Aug 1992
METAL HALIDE LIGHT SOURCE MODEL LM 250
K915274 · Pentax Precision Instrument Corp. · Jan 1992
CUDA SURGICAL LIGHT
K901491 · Cuda Products Co. · Jun 1990
MODEL M2-150/I-150/M2-150T/M3-150/M2-150,300-300
K893491 · Cuda Products Co. · Jun 1989
PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDO. W/PICK
K875004 · Advanced Surgical Products, Inc. · Mar 1988
PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA.
K875005 · Advanced Surgical Products, Inc. · Mar 1988